scholarly journals A randomized double-blinded clinical trial to evaluate the safety and efficacy of a novel superelastic nickel–titanium spinal rod in adolescent idiopathic scoliosis: 5-year follow-up

2017 ◽  
Vol 27 (2) ◽  
pp. 327-339 ◽  
Author(s):  
Jason Pui Yin Cheung ◽  
Dino Samartzis ◽  
Kelvin Yeung ◽  
Michael To ◽  
Keith Dip Kei Luk ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adolescent Idiopathic Scoliosis ◽  
Idiopathic Scoliosis ◽  
Nickel Titanium ◽  
Safety And Efficacy ◽  
Double Blinded

scholarly journals Does curve pattern impact on the effects of physiotherapeutic scoliosis specific exercises on Cobb angles of participants with adolescent idiopathic scoliosis: A prospective clinical trial with two years follow-up

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0245829
Author(s):  
Yunli Fan ◽  
Michael K. T. To ◽  
Eric H. K. Yeung ◽  
Jianbin Wu ◽  
Rong He ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adolescent Idiopathic Scoliosis ◽  
Idiopathic Scoliosis ◽  
Cobb Angle ◽  
Repeated Measurements ◽  
Prospective Clinical Trial ◽  
Home Exercise ◽  
Testing Time ◽  
Curve Pattern

Background Current clinical evidence suggests that a well-planned physiotherapeutic scoliosis specific exercise (PSSE) program is effective for scoliosis regression. Objectives We investigated the effect of curve patterns on Cobb angles with PSSE. Methods This was a non-randomized prospective clinical trial that recruited participants with adolescent idiopathic scoliosis between January and June 2017. Participants were grouped by curve pattern into major thoracic and major lumbar groups. An outpatient-based PSSE program was conducted with the following schedule of intensive exercise: ≥ 1 session of supervised PSSE per month and > 30min of home exercise 5 days/week in the first 6 months, after which exercise frequency was reduced to 1 session of supervised PSSE every three months and > 30min of home exercise 5 days/week until 2 years after study initiation. Radiographic Cobb angle progressions were identified at the 1, 1.5 and 2-year follow-ups. A mixed model analysis of variance (ANOVA) was performed to examine the differences in Cobb angles between groups at four testing time points. The two-tailed significance level was set to 0.05. Results In total, 40 participants were recruited, including 22 with major thoracic curves (5 males and 17 females; mean age 13.5±1.8 years; Cobb angle 18–45 degrees) and 18 with major lumbar curves (7 males and 11 females; mean age 12.7±1.7 years; Cobb angle 15–48 degrees). Curve regressions, namely the reduction of Cobb angles between 7 to 10 degrees were noted in 9.1% of participants in the major thoracic group; reductions of 6 to 13 degrees were noted in 33.3% of participants in the major lumbar group at the 2-year follow-up. Repeated measurements revealed a significant time effect (F2.2,79.8 = 4.1, p = 0.02), but no group (F2.2,79.8 = 2.3, p = 0.1) or time × group (F1,37 = 0.97, p = 0.3) effects in reducing Cobb angles after 2 years of PSSE. A logistic regression analysis revealed that no correlation was observed between curve pattern and curve regression or stabilization (OR: 0.2, 95% CI: 0.31–1.1, p = 0.068) at the 2-year follow-up. Conclusion This was the first study to investigate the long-term effects of PSSE in reducing Cobb angles on the basis of major curve location. No significant differences in correction were observed between major thoracic and major lumbar curves. A regression effect and no curve deterioration were noted in both groups at the 2-year follow-up. Trial registration ChiCTR1900028073.

scholarly journals Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)

2020 ◽  
Author(s):  
Mayla Gabriela Silva Borba ◽  
Fernando Fonseca Almeida Val ◽  
Vanderson Souza Sampaio ◽  
Marcia Almeida Araújo Alexandre ◽  
Gisely Cardoso Melo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Total Dose ◽  
Sample Size ◽  
Adjunctive Therapy ◽  
Historical Data ◽  
Qtc Prolongation ◽  
Limited Sample ◽  
Safety And Efficacy ◽  
Double Blinded

SummaryBackgroundThere is no specific antiviral therapy recommended for the disease caused by SARS-CoV-2 (COVID-19). Recent publications have drawn attention to the possible benefit of chloroquine (CQ). Our study aimed to comprehensively evaluate the safety and efficacy of two different CQ dosages in patients with established severe COVID-19.MethodsWe performed a parallel, double-blinded, randomized, phase IIb clinical trial, aiming to assess safety and efficacy of two different CQ dosages as adjunctive therapy of hospitalized patients with SARS in Manaus, Brazilian Amazon. Eligible participants were allocated to receive orally or via nasogastric tube high dose CQ (600mg CQ twice daily for 10 days or total dose 12g); or low dose CQ (450mg for 5 days, twice daily only on the first day, or total dose 2.7g). In addition, all patients received ceftriaxone and azithromycin. This study was registered with ClinicalTrials.gov, number NCT04323527.FindingsOut of a pre-defined 440 patients sample size, 81 patients were enrolled. The high dosage CQ arm presented more QTc>500ms (18.9%), and a trend toward higher lethality (39%) than the lower dosage. Fatality rate until day 13 was 27% (95%CI=17.9-38.2%), overlapping with the CI of historical data from similar patients not using CQ (95%CI=14.5-19.2%). In 27 patients with paired samples, respiratory secretion at day 4 was negative in only six patients (22%).InterpretationPreliminary findings suggest that the higher CQ dosage (10-day regimen) should not be recommended for COVID-19 treatment because of its potential safety hazards. Such results forced us to prematurely halt patient recruitment to this arm. Given the enormous global push for the use of CQ for COVID-19, results such as the ones found in this trial can provide robust evidence for updated COVID-19 patient management recommendations.FundingThis study was funded by the Government of the Amazonas State, Farmanguinhos (Fiocruz), SUFRAMA, CAPES, FAPEAM, and federal funds granted by a coalition of Brazilian senators.Research in contextEvidence before this studyBefore the CloroCovid-19 trial began, to our knowledge, there were no published reports of robust clinical studies on the safety and/or efficacy of chloroquine (CQ) and/or hydroxychloroquine (HCQ) for the treatment of COVID-19 during the recent 2020 pandemic. We searched PubMed and also MedRxiv.org (pre-print server for health sciences, without peer review), without any language restrictions and including Chinese publications, for studies published between Dec 2019 and April 5, 2020, using the search terms ‘COVID-19, coronavirus, SARS-Cov-2’. We found three non-randomized studies with limited sample sizes in which (1) HCQ use led to a decrease in SARS-Cov-2 detected in respiratory secretions five days after treatment, together with azithromycin (France, 36 patients); (2) HCQ use shortened time to clinical recovery (China, 62 patients); and (3) CQ was superior to control treatment in inhibiting the exacerbation of pneumonia, improving lung imaging findings, and promoting virus-negative conversion and shortening the disease course (China, 100 patients). We found no published studies comparing different dosages of CQ/HCQ and their thorough safety assessment.Added value of this studyIn a larger patient population, we found that a higher dosage of CQ for 10 days presented toxicity red flags, particularly affecting QTc prolongation. The limited sample size recruited so far does not allow to show any benefit regarding treatment efficacy, however the higher fatality associated with the higher dosage by day 13 of follow-up resulted in a premature halting of this arm. This is the first double-blinded, randomized clinical trial addressing different dosages of CQ for the treatment of severe patients with COVID-19 in the absence of a control group using placebo. Due to the impossibility of not using the drug recommended at the national level, we used historical data from the literature to infer comparisons for lethality endpoints. Follow-up until day 28 is ongoing with a larger sample size, in which long-term lethality will be better estimated.Implications of all the available evidenceThe preliminary findings from CloroCovid-19 trial suggest that the higher dosage of CQ (12 g total dose over 10 days) in COVID-19 should not be recommended because of safety concerns regarding QTc prolongation and increased lethality, in the Brazilian population, and more often in older patients in use of drugs such as azithromycin and oseltamivir, which also prolong QTc interval. Among patients randomized to the lower dosage group (5 days of treatment, total dose 2.7 g), given the limited number of patients so far enrolled, it is still not possible to estimate a clear benefit of CQ in patients with severe ARDS. Preliminary data on viral clearance in respiratory secretions in our confirmed cases are also indicative of little effect of the drug at high dosage. More studies initiating CQ prior to the onset of the severe phase of the disease are urgently needed.

Upper instrumented vertebra to the right of the lowest instrumented vertebra as a predictor of an increase in the main thoracic curve after selective posterior fusion for the thoracolumbar/lumbar curve in Lenke type 5C adolescent idiopathic scoliosis: multicenter study on the relationship between fusion area and surgical outcome

2019 ◽  
Vol 31 (6) ◽  
pp. 857-864 ◽  
Author(s):  
Hiroki Oba ◽  
Jun Takahashi ◽  
Sho Kobayashi ◽  
Tetsuro Ohba ◽  
Shota Ikegami ◽  
...  
Keyword(s):  
Adolescent Idiopathic Scoliosis ◽  
Idiopathic Scoliosis ◽  
Cobb Angle ◽  
Posterior Fusion ◽  
Main Thoracic ◽  
Lowest Instrumented Vertebra ◽  
Line Tilt ◽  
The Right ◽  
Upper Instrumented Vertebra

OBJECTIVEUnfused main thoracic (MT) curvatures occasionally increase after selective thoracolumbar/lumbar (TL/L) fusion. This study sought to identify the predictors of an unacceptable increase in MT curve (UIMT) after selective posterior fusion (SPF) of the TL/L curve in patients with Lenke type 5C adolescent idiopathic scoliosis (AIS).METHODSForty-eight consecutive patients (44 females and 4 males, mean age 15.7 ± 2.5 years, range 13–24 years) with Lenke type 5C AIS who underwent SPF of the TL/L curve were analyzed. The novel “Shinshu line” (S-line) was defined as a line connecting the centers of the concave-side pedicles of the upper instrumented vertebra (UIV) and lowest instrumented vertebra (LIV) on preoperative radiographs. The authors established an S-line tilt to the right as S-line positive (S-line+, i.e., the UIV being to the right of the LIV) and compared S-line+ and S-line− groups for thoracic apical vertebral translation (T-AVT) and MT Cobb angle preoperatively, early postoperatively, and at final follow-up. The predictors for T-AVT > 20 mm at final follow-up were evaluated as well. T-AVT > 20 mm was defined as a UIMT.RESULTSAmong the 48 consecutively treated patients, 26 were S-line+ and 22 were S-line−. At preoperative, early postoperative, and final follow-up a minimum of 2 years later, the mean T-AVT was 12.8 mm (range −9.3 to 32.8 mm), 19.6 mm (range −13.0 to 41.0 mm), and 22.8 mm (range −1.9 to 68.7 mm) in the S-line+ group, and 10.8 mm (range −5.1 to 27.3 mm), 16.2 mm (range −11.7 to 42.1 mm), and 11.0 mm (range −6.3 to 26.9 mm) in the S-line− group, respectively. T-AVT in S-line+ patients was significantly larger than that in S-line− patients at the final follow-up. Multivariate analysis revealed S-line+ (odds ratio [OR] 23.8, p = 0.003) and preoperative MT Cobb angle (OR 7.9, p = 0.001) to be predictors of a UIMT.CONCLUSIONSS-line+ was defined as the UIV being to the right of the LIV. T-AVT in the S-line+ group was significantly larger than in the S-line− group at the final follow-up. S-line+ status and larger preoperative MT Cobb angle were independent predictors of a UIMT after SPF for the TL/L curve in patients with Lenke type 5C AIS. Surgeons should consider changing the UIV and/or LIV in patients exhibiting S-line+ during preoperative planning to avoid a possible increase in MT curve and revision surgery.

Safety and Efficacy of Isola Instrumentation and Arthrodesis for Adolescent Idiopathic Scoliosis

Spine ◽  
2004 ◽  
Vol 29 (18) ◽  
pp. 2013-2023 ◽  
Author(s):  
Marc Asher ◽  
Sue Min Lai ◽  
Douglas Burton ◽  
Barbara Manna ◽  
Andrew Cooper
Keyword(s):  
Adolescent Idiopathic Scoliosis ◽  
Idiopathic Scoliosis ◽  
Safety And Efficacy

Is Routine Postoperative Radiologic Follow-up Justified in Adolescent Idiopathic Scoliosis?

2013 ◽  
Vol 1 (3) ◽  
pp. 223-228 ◽  
Author(s):  
Alba Vila-Casademunt ◽  
Ferran Pellisé ◽  
Montse Domingo-Sàbat ◽  
Juan Bagó ◽  
Antonia Matamalas ◽  
...  
Keyword(s):  
Adolescent Idiopathic Scoliosis ◽  
Idiopathic Scoliosis

Should L3 be selected as the lowest instrumented vertebra in patients with Lenke type 5C adolescent idiopathic scoliosis whose lowest end vertebra is L4?

2021 ◽  
pp. 1-10
Author(s):  
Tomohiro Banno ◽  
Yu Yamato ◽  
Hiroki Oba ◽  
Tetsuro Ohba ◽  
Tomohiko Hasegawa ◽  
...  
Keyword(s):  
Adolescent Idiopathic Scoliosis ◽  
Idiopathic Scoliosis ◽  
Curve Progression ◽  
Global Alignment ◽  
Fusion Surgery ◽  
Radiographic Outcomes ◽  
Lowest Instrumented Vertebra ◽  
Upper Instrumented Vertebra ◽  
Coronal Decompensation

OBJECTIVE L3 is most often selected as the lowest instrumented vertebra (LIV) to conserve mobile segments in fusion surgery; however, in cases with the lowest end vertebra (LEV) at L4, LIV selection as L3 could have a potential risk of correction loss and coronal decompensation. This study aimed to compare the clinical and radiographic outcomes depending on the LEV in adolescent idiopathic scoliosis (AIS) patients with Lenke type 5C curves. METHODS Data from 49 AIS patients with Lenke type 5C curves who underwent selective thoracolumbar/lumbar (TL/L) fusion to L3 as the LIV were retrospectively analyzed. The patients were classified according to their LEVs into L3 and L4 groups. In the L4 group, subanalysis was performed according to the upper instrumented vertebra (UIV) level toward the upper end vertebra (UEV and 1 level above the UEV [UEV+1] subgroups). Radiographic parameters and clinical outcomes were compared between these groups. RESULTS Among 49 patients, 32 and 17 were in the L3 and L4 groups, respectively. The L4 group showed a lower TL/L curve correction rate and a higher subjacent disc angle postoperatively than the L3 group. Although no intergroup difference was observed in coronal balance (CB), the L4 group showed a significantly higher main thoracic (MT) and TL/L curve progression during the postoperative follow-up period than the L3 group. In the L4 group, the UEV+1 subgroup showed a higher absolute value of CB at 2 years than the UEV subgroup. CONCLUSIONS In Lenke type 5C AIS patients with posterior selective TL/L fusion to L3 as the LIV, patients with their LEVs at L4 showed postoperative MT and TL/L curve progression; however, no significant differences were observed in global alignment and clinical outcome.

Preoperative pelvic obliquity: possible relation to postoperative coronal decompensation in thoracolumbar/lumbar adolescent idiopathic scoliosis

2021 ◽  
pp. 1-10
Author(s):  
Tomohiro Banno ◽  
Yu Yamato ◽  
Hiroki Oba ◽  
Tetsuro Ohba ◽  
Tomohiko Hasegawa ◽  
...  
Keyword(s):  
Adolescent Idiopathic Scoliosis ◽  
Idiopathic Scoliosis ◽  
Clinical Outcomes ◽  
Pelvic Obliquity ◽  
Posterior Fusion ◽  
Lumbar Curve ◽  
Fusion Surgery ◽  
The Right ◽  
Coronal Decompensation

OBJECTIVE Pelvic obliquity is frequently observed in patients with adolescent idiopathic scoliosis with thoracolumbar/lumbar (TL/L) curve. This study aimed to assess pelvic obliquity changes and their effects on clinical outcomes of posterior fusion surgery. METHODS Data in 80 patients (69 with type 5C and 11 with type 6C adolescent idiopathic scoliosis) who underwent posterior fusion surgery were retrospectively analyzed. Pelvic obliquity was defined as an absolute pelvic obliquity angle (POA) value of ≥ 3°. The patients were divided into groups according to preoperative pelvic obliquity. Moreover, patients with preoperative pelvic obliquity were divided based on POA change from preoperative values versus 2 years postoperatively. Patients were divided based on the presence of selective or nonselective TL/L fusion. Radiographic parameters and clinical outcomes were compared between these groups. RESULTS Among 80 patients, 41 (51%) showed preoperative pelvic obliquity, and its direction was upward to the right for all cases. Coronal decompensation 2 years postoperatively was significantly elevated in patients with preoperative pelvic obliquity (p < 0.05). Thirty-two patients (40%) displayed pelvic obliquity 2 years postoperatively. Among 41 patients with preoperative pelvic obliquity, 22 patients (54%) were in the group with a decrease in POA, and 19 were in the group with no decrease. The group with no decrease in POA showed significant TL/L curve progression throughout the postoperative follow-up period. The patients with nonselective fusion showed a significantly lower incidence of pelvic obliquity at 2 years postoperatively. CONCLUSIONS Postoperative coronal decompensation more frequently occurred in patients with preoperative pelvic obliquity than in those without pelvic obliquity preoperatively. In addition, postoperative pelvic obliquity changes may be related to residual lumbar curve behavior.

Sign in / Sign up

Export Citation Format

Share Document